Trial Master File (TMF) Specialist (EDG-2026014)

Role Summary

The Trial Master File (TMF) Specialist will assist the Clinical Documentation Manager with overseeing day-to-day TMF tasks, ensuring quality control across studies, and supporting regulatory compliance.

Responsibilities

• Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF.
• Act as a TMF expert for all studies and provide guidance on best practices.
• Collaborate with Study Teams and CRO partners to ensure all records are successfully catalogued/filed.
• Assist Clinical Documentation Manager in the creation/execution of study specific TMF Plans, structure, and periodic TMF reviews.
• Oversee TMF maintenance performed by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings.
• Champion best practices for building and maintaining TMF health.
• Assist in periodic metrics reporting such as updating Expected Documents Lists, updating dashboards, and running metrics reports.
• Read, understand, and comply with all workplace health and safety policies; safe work practices; and company policies and procedures.
• Perform other duties as assigned by supervisor.

Qualifications

• Required: 3+ years of experience working in TMF activities.
• Required: Extensive experience with the DIA TMF Reference Model, ALCOA+ standard and document management best practices.
• Required: Knowledge and direct experience with Veeva Clinical eTMF and/or other eTMF platforms.
• Required: Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, Clinical Trial Inspection Readiness, and International Council for Harmonization E6(R3).
• Preferred: Fundamental knowledge of the conduct of clinical trials.